Why do hospitals not follow a best practice from the FDA— process validation using IQ/OP/PQ?
A. This is an interesting question. Instead of asking about hospitals we might equally well ask it about teams, groups, and individuals. Why does anyone not follow best practice? I think the answer probably lies in the old discipline of applied behavior analysis (ABA). ABA suggests that the strongest motivators are those which are soon, certain, and positive. The reason best practices are not followed is usually because they are not perceived to lead immediately to the best possible outcome with complete certainty. For a more thorough treatment of this question, I recommend reading the following article. Repenning, N. and J. Sterman (2001). Nobody Ever Gets Credit for Fixing Defects that Didn’t Happen: Creating and Sustaining Process Improvement, California Management Review, 43, 4: 64-88. Q. When completing a FMEA, is there a standard “weighting” standard for the numerators such as the ones available for FMEA in automotive/manufacturing? A. There is no standard scale for the factors t
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